Stent delivery device

ABSTRACT

A unidirectional handle device for an endoluminal device includes an outer tubular member and an elongate inner member slidably received in the outer tubular member. The unidirectional handle includes a handle member, a needle bearing clutch disposed in the handle member, a control member guide, and shaft rotatable in a single direction disposed within the handle member. The shaft is rotatable in a single direction by its engagement with the needle bearing clutch. The shaft is in rotational engagement with the outer tubular member of the endoluminal device. The outer tubular member is slidable from a distal position to a proximal position when the shaft is rotated in the single direction. The unidirectional handle device provides substantially no backlash of the outer tubular member. In addition, the unidirectional handle device advantageously produces a tension-retaining effect during use.

RELATED APPLICATION DATA

This application is a continuation of U.S. patent application Ser. No.10/373,500, filed Feb. 24, 2003, which is a continuation of applicationSer. No. 09/613,872, filed Jul. 10, 2000, now U.S. Pat. No. 6,527,779,the disclosures of which is expressly incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to catheter-based systems fortreating a remote location within a patient, and more particularly tohandles for stent delivery systems, electrophysiology devices and thelike, which include a catheter and a retractable sheath thereon.

BACKGROUND OF THE INVENTION

Devices having a retractable sheath associated with a catheter are usedto treat a variety of conditions using endoluminal methods instead ofopen surgical procedures. For example, angioplasty and stentimplantation procedures are often used to treat atherosclerotic diseaseor other occlusive conditions in blood vessels, such as the coronary andcarotid arteries. During angioplasty, for example, a catheter having anuninflated balloon on its distal end is percutaneously introduced into apatient's vasculature and advanced to a target treatment location, suchas a stenosis within a blood vessel. Once the balloon is properly placedacross the stenosis, the balloon is inflated to enlarge the lumen at thelocation. The balloon is then deflated, the inflation/deflationprocedure may be repeated, and then the catheter is then withdrawn fromthe patient's body.

Often in conjunction with angioplasty, a stent or other tubularprosthesis may be implanted within a stenosis to scaffold the locationand prevent it from contracting or otherwise becoming obstructed again.The stent, in a contracted condition, is generally placed upon acatheter, possibly over a balloon. The catheter is advanced to thetarget stenosis until the stent is adjacent to the location, and thenthe stent is deployed and substantially anchored at the location. Thestent may be biased to expand to an enlarged condition and/or may beexpanded with the aid of a balloon, as with plastically deformablestents, until the stent substantially engages the wall of the vessel.Once the stent is implanted, the delivery catheter is withdrawn from thepatient.

Similarly for ablation procedures and the like, a catheter including anarray of electrodes, for example, on an expandable basket assembly, maybe provided. The device may be introduced into a body lumen, for examplethrough the patient's vasculature into the heart, to treat conditions,such as heart arrhythmia.

With any of these systems, a sheath may be provided over the distal endof the catheter to protect the components on the distal end, such as aballoon, a stent, an array of electrodes, and the like. The sheath maybe advanced distally over the proximal end of the catheter until itcovers the distal end and its components, or, alternatively, the distalend of the catheter may be introduced into the sheath, and advanceduntil it is proximate the distal end of the sheath. Once the distal endof the catheter is properly positioned at a desired location within abody lumen, the sheath may be retracted to expose the distal end of thecatheter. After treatment, the sheath may be advanced back over thedistal end of the catheter, and the entire device withdrawn from thepatient.

To cause the sheath to retract, the proximal end of the sheath outsidethe patient may simply be pulled while holding the catheter in a fixedposition. This, however, may not provide very precise control of theretraction of the sheath. To provide improved control, handle deviceshave been proposed that include a wheel and screw mechanism. A wheelextending around the circumference of the handle is coupled to a screwmechanism engaging the sheath and the catheter. As the wheel is rotatedabout the longitudinal axis of the handle, the screw mechanism directsthe sheath axially with respect to the catheter.

With such devices, however, it may be difficult to remember whichdirection, i.e., clockwise or counterclockwise, is appropriate either toretract or advance the sheath with respect to the catheter. This may beparticularly important when immediate action is necessary because of acomplication during a procedure. Moreover, in such devices, it ispossible to advance the sheath in the distal direction during and afterdeployment of the device, such as a stent, on the distal end of thecatheter. This distal movement may result in the improper placement andunwanted movement of the deployed device. This distal movement of thesheath is particularly problematic in the deployment of stents or othertubular prostheses. It is preferred that a catheter-sheath system haveonly unidirectional motion, i.e., only permit retraction of the sheathin the proximal direction.

Another disadvantage in current screw-type devices is that the devicesare often complicated, including many parts which may be difficult toassemble and/or expensive to make.

Accordingly, there is a need for more intuitive, more simple, and/orless expensive devices for controlling catheter-sheath systems.

SUMMARY OF THE INVENTION

In a first aspect of the invention, a unidirectional handle device foran endoluminal device includes an outer tubular member and an elongateinner member slidably received in the outer tubular member. The elongateinner member is detachably mounted to the unidirectional handle device.The unidirectional handle device includes a handle member, a needlebearing clutch disposed in the handle member, a control member guide inthe handle member, and a shaft. The shaft is disposed in the handlemember and rotatable in a single direction. The shaft engages with theneedle bearing clutch and is in rotational engagement with the outertubular member. The outer tubular member is slidable from a distalposition to a proximal position when the shaft is rotated in the singledirection.

In another aspect of the invention, the unidirectional handle includes ahandle member, a needle bearing clutch disposed in the handle member, acontrol member slidably disposed in the handle member, and a shaft. Thecontrol member is mounted at one end thereof to the outer tubularmember. The shaft is mounted to the handle member and rotatable in asingle direction by engaging with the needle bearing clutch. The shaftfurther includes a gear mounted thereon, wherein the gear is engagedwith the control member. The control member is slidable from a distalposition to a proximal position and not slidable from a proximalposition to a distal position.

In still another aspect of the invention, the unidirectional handledevice includes a handle member including a grip portion and a bodyportion. The body portion includes a transverse bore and a controlmember guide therein. A needle bearing clutch is disposed in a clutchrecess located in the body portion, the needle bearing clutch and theclutch recess are coaxial with the transverse bore. A control member isslidably moveable within the control member guide of the body portionwith the control member engaged at one end with the outer tubularmember. The handle device includes a control knob including a shaft andgear thereon. The shaft engages with the needle bearing clutch while thegear engages with the control member. The control member is slidablefrom a distal position to a proximal position.

In still another aspect of the invention, the handle device includes ahandle member, a needle bearing clutch disposed in the handle member,and a control member slidably disposed in the handle member. The controlmember is mounted at one end thereof to a hydrostatic valve assembly. Acontrol knob is mounted to the handle member and rotatable in a singledirection, the control knob including a shaft engaging with the needlebearing clutch. The shaft further includes a gear engaged with thecontrol member, the control member being slidable from a distal positionto a proximal position and not slidable from a proximal position to adistal position.

In yet another aspect of the invention, a unidirectional handle devicefor an endoluminal device includes an outer tubular member and anelongate inner member slidably received in the outer tubular member. Theunidirectional handle includes a handle member including a grip portionand a body portion, the body portion including a transverse bore and acontrol member guide therein. The body portion further includes an innermember recess for detachably mounting the elongate inner member. Aneedle bearing clutch is disposed in a clutch recess located in the bodyportion, wherein the needle bearing clutch and the clutch recess arecoaxial with the transverse bore. A control member is slidably moveablewithin the control member guide of the body portion, the control memberfurther includes a rail portion including a plurality of teeth thereon.The control member is releasably engaged at one end thereof with theouter tubular member. A control knob is provided and includes a shaftand gear thereon. The shaft engages with the needle bearing clutch andthe gear engages with the teeth of the rail portion. The control memberis slidable from a distal position to a proximal position and notslidable from a proximal position to a distal position.

In another separate aspect of the invention, a catheter-sheath systemfor delivering a stent to a patient includes an outer tubular member, anelongate inner member slidably received in the outer tubular member, anda handle device for imparting unidirectional movement of the outertubular member relative the elongate inner member. The handle includes ahandle member, a needle bearing clutch disposed in the handle member, acontrol member slidably disposed in a control member guide in the handlemember. The control member is engaged at one end thereof to the outertubular member. A control knob is mounted to the handle member androtatable in a single direction. The control knob includes a shaftengaging with the needle bearing clutch. The shaft further includes agear engaged with the control member, the control member being slidablefrom a distal position to a proximal position and not slidable from aproximal position to a distal position.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded view of the handle device showing the handlemember, one aspect of the control member, and the control knob.

FIG. 2(a) is an end view of the handle device showing the handle member,the roller bearing clutch, and the control knob.

FIG. 2(b) is an end view of one aspect of the control member.

FIG. 3 is a side view of the handle member.

FIG. 4 is a side view of an endoluminal device showing the outer tubularmember, the hemostatic valve assembly, and the elongate inner member.

FIG. 5(a) is an enlarged side view of a stent contained within the outertubular member and the elongate inner member disposed adjacent to thestent.

FIG. 5(b) is an enlarged side view of a stent contained within the outertubular member, wherein the stent is located on the elongate innermember.

FIG. 6 is a side view of one embodiment of the control member and outertubular member.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now in detail to the drawings, FIGS. 1, 3, and 4 show a handledevice 2 in accordance with the invention that may include as few asthree parts, namely, a handle member 4, a shaft 54, and needle bearingclutch 130.

In one preferred embodiment of the invention, the handle device 2includes a handle member 4, a control knob 50, and a control member 30.The handle member 4, control knob 50, and control member 30 can be madeof materials such as molded or machined plastic, or stainless steel. Anymaterial commonly used within the medical device field can be used inthe handle device 2.

Turning in more detail to the handle member 4, the handle member 4preferably comprises a grip portion 6 and a body portion 8. The gripportion 6 is generally tubular in shape and projects from the bodyportion 8 at an oblique angle. In use, the grip portion 6 preferablyextends in a forward or distal direction away from the user.

Referring to FIGS. 1, 2, and 3, the body portion 8 includes a transversebore 10 passing through the entire body portion 8, As best seen in FIG.2, a needle bearing clutch recess 12 and a gear recess 14 are located onopposing sides of the body portion 8. Both the needle bearing clutchrecess 12 and the gear recess 14 are coaxial with the transverse bore10.

Also located within the body portion 8 is a control member guide 16. Thecontrol member guide 16 preferably passes entirely through the bodyportion 8. In this manner, the control member guide 16 is preferably abore through the body portion 8. It should be understood, however, thatthe control member guide 16 can be located on a side of the body portion8 (having one side exposed to the outside environment) or the controlmember guide 16 can be a separate component external to the body portion8. In addition, the control member guide 16 is preferably substantiallyperpendicular to the transverse bore 10. Of course, other orientationsof the transverse bore 10 and control member guide 16 are possible,i.e., parallel, angular, and the like, and are intended to fall withinthe scope of the invention.

Referring now to FIGS. 1 and 2, the control member guide 16 preferablyhas one or more guide pins 24 projecting therein. The guide pins 24preferably are affixed to the body portion 8. The guide pins 24 slidablyengage with a groove 36 located in the control member 30 when thecontrol member 30 is positioned inside the control member guide 16. Thecontrol member guide 16 also includes an opening 22 therein, as shown inFIG. 2, in communication with the gear recess 14. The opening 22 allowsthe gear 56 of the control knob 50 to engage with teeth 34 of thecontrol member 30. In this way, movement of the control knob 50 controlsmovement of the control member 30.

Referring to FIGS. 1, 2, and 3, the body portion 8 of the handle member4 includes an inner member recess 20 along one side of the body portion8. The inner member recess 20 is used to detachably mount an elongateinner member 90. The elongate inner member 90 is preferably press-fitinto the inner member recess 20 by the user. In this manner, theelongate inner member 90 is fixed relative to the handle device 2. Theelongate inner member 90 can comprise any number of structures such as,by way of illustration and not limitation, catheters, guidewires,bumpers, and the like. With reference to FIG. 4, the elongate innermember 90 includes at a proximal end thereof a proximal attachmentmember 96. The proximal attachment member 96 is press-fit or the likeinto the inner member recess 20. The proximal attachment member 96advantageously has a corresponding profile and geometry as the innermember recess 20. In this regard, the elongate inner member 90 isproperly secured to the handle device 2. Threads 98 or other connectorsmay be located on a proximal end of the proximal attachment member 96 sothe elongate inner member 90 may attach to additional devices (notshown).

With reference to FIG. 4, a description of the components of one exampleof an endoluminal device I will now be described. The endoluminal device1, in its most general format, can comprise an elongate inner member 90and an outer tubular member 110. In FIG. 4, the outer tubular member 110includes a flexible sheath 114 and a separate hemostatic valve assembly60. It should be understood, however, that the outer tubular member 110can comprise only one component such as flexible sheath 114 or the like.

Flexible sheath 114 includes a lumen therein (not shown) for the passageof the elongate inner member 90. The flexible sheath may include agenerally cone-shaped proximal transition member 112 to aid in fasteningthe flexible sheath 114 to the hemostatic valve assembly 60.

The hemostatic valve assembly 60 has a generally tubular body 62 havinga central lumen 64 therein. The central lumen 64 is in fluidcommunication with the lumen of the proximal transition member 112 (notshown) and flexible sheath 114 lumen (not shown) when attached to thehemostatic valve assembly 60. The hemostatic valve assembly 60preferably includes an optional flush port 80 having a flush lumen 82therein that is in fluid communication with the central lumen 64 of thehemostatic valve assembly 60. The flush port 80 may be used to introducefluid into the flush lumen 82 and central lumen 64 as will beappreciated by those skilled in the art. A distal engagement member 66is located at the distal end of the hemostatic valve assembly 60. Thedistal engagement member 66 is preferably rotational about its axis. Thedistal engagement member 66 is sealed with respect to the hemostaticengagement member 60 via seal 70. The distal engagement member 66includes threads 68 that engage in a sealed fashion with correspondingthreads 116 on the proximal transition member 112 of the flexible sheath114.

The proximal end of the hemostatic valve assembly 60 includes a proximalengagement member 72 that has a generally tubular construction. On theexterior of the proximal engagement member 72 are located a plurality ofthreads 74. A seal 78 is affixed inside the hemostatic valve assembly 60adjacent to the proximal engagement member 72.

Still referring to FIG. 4, the endoluminal device 1 comprises anelongate inner member 90. A catheter is shown in FIG. 4 as the elongateinner member 90. Preferably, the elongate inner member 90 includes alumen therein (not shown) such that a guidewire or the like can be usedto feed and position the elongate inner member 90 into the vasculatureof a patient. An end cup 76 surrounds the elongate inner member 90 whenpositioned inside the hemostatic valve assembly 60. The end cup 76includes an internal tubular projection 77 therein having a lumen forthe passage of the elongate inner member 90. A seal 79 is advantageouslylocated distal to the end cup 76. Threads 84 are located inside the endcup 76. During operation, the elongate inner member 90 is fed throughthe internal tubular projection 77 of the end cup 76, through the seals78, 79, and into the central lumen 64 of the hemostatic valve assembly60. When the end cup 76 is screwed onto the proximal engagement member72, a seal is formed at the proximal end of the hemostatic assembly 60.A sealing engagement is made by compressing the seal 79 between the seal78 and the tubular projection 77.

An optional flexible tip 94 can be affixed to the end of the elongateinner member 90 when the elongate member is not used as a bumper, i.e.,when a stent 150 is placed distal to the elongate inner member 90 insidethe flexible sheath 114. The flexible tip 94, when used, includes alumen therein (not shown) so a guidewire or the like can pass through.

The proximal end of the elongate inner member 90 is attached to theproximal attachment member 96. The proximal attachment member alsoincludes a lumen therein (not shown) in communication with the lumen ofthe elongate inner member 90. When a guidewire or the like is used, itis fed into the elongate inner member 90 through the proximal attachmentmember 96.

Referring now to FIGS. 1 and 2, the control knob 50 and control member30 will now be described. The control knob 50 preferably includes ageneral circular wheel portion 52. While a circular-shaped wheel 52 ispreferred, other shapes and geometries are possible and within the scopeof the invention. A shaft 54 projects in one direction from the wheel 52and is fixedly secured thereto. The shaft 54 projects generallyperpendicular to the plane of the wheel 52. The diameter of the shaft 54is approximately equal to the inner diameter of the transverse bore 10.A gear 56 is fixedly secured onto the shaft 54 and includes a pluralityof teeth 57. During operation, the control knob 50 is inserted into thehandle device 2. The shaft 54 passes through the transverse bore 10 andinto a needle-bearing clutch 130 located therein. While the control knob50 is preferred due to the incorporation of the wheel portion 52, itshould be appreciated that the handle device 2 may operate within thescope of the invention using only a shaft 54.

The control member 30 preferably includes a rail 32 and an engagementmember 38. The rail 32 includes a groove 36 on the upper side thereof.The groove 36 engages with guide pins 24 in the handle member 4 when thecontrol member 30 is inserted into the handle device 2. Teeth 34 arelocated along the underside of the rail 32. The teeth 34 engage withcorresponding teeth 57 of the gear 56 of the control knob 50 when thecontrol member 30 is positioned inside the handle device 2 with thecontrol knob 50 in place. At one end of the rail 32 is located anengagement member 38. The engagement member 38 includes a recess 40therein for engaging with the outer tubular member 110 or hemostaticvalve assembly 60. As shown in FIGS. 1 and 2, the recess 40 engages withthe tubular body 62 of the hemostatic valve assembly 60. In thisembodiment, the engagement member 38 snaps-on and/or is press-fit ontothe hemostatic valve assembly 60. It should be understood, however, thatthe engagement member 38 can directly affix to the outer tubular member110 on any component or structure secured to the outer tubular member110. The engagement member 38 and in a more general sense the controlmember 30 serve to forcibly move the outer tubular member 110 relativeto the fixed elongate inner member 90.

FIGS. 1, 2, and 3 show the needle bearing clutch 130. The needle bearingclutch 130 has an outer chamber diameter substantially equal to theneedle bearing clutch recess 12. The needle bearing clutch 130 issecured to the body portion 8 of the handle device 2 by press-fitting orthrough use of an adhesive or the like. The needle bearing clutch 130generally includes a plurality of needle rollers held within a cageinside an outer cup. Springs are associated with each of the needlerollers. The needle bearing clutch 130 is designed to transmit torquebetween the shaft 54 and the needle bearing clutch 130 in one directionand allow free overrun in the opposite direction. Generally, preciselyformed interior ramps provide surfaces against which the needle rollerswedge to positively transmit a locking torque when the shaft 54 isturned in one direction. The needle bearing clutch 130 is preferablyobtained from the Torrington Company, 59 Field Street, P.O. BOX 1008,Torrington, Conn. 06790-1008. The needle bearing clutch 130advantageously permits the transition from overrun (rotation) to lockwith minimal lost motion or backlash. In this regard, the handle device2 has substantially no backlash motion of the outer tubular member 110.Substantially no backlash is meant to indicate that there is noappreciable movement of the outer tubular member 110 in the distaldirection that would destroy the tension-retaining effect of the handledevice 2. This anti-backlash feature is particularly advantageous forthe clinical deployment of self-expanding stents 150. Specifically, theanti-backlash feature prevents the flexible sheath 114 or outer tubularmember 110 from “springing back” if the clinician stops the motion orreleases the input torque on the control knob 50. In this fashion, theneedle bearing clutch 130 provides for slow, controlled retraction ofthe outer tubular member 110 or flexible sheath 114.

FIGS. 5(a) and 5(b) show a close-up view of the distal end of theflexible sheath 114 containing a loaded stent 150 and elongate innermember 90. In FIG. 5(a), the stent 150 is loaded adjacent to theelongate inner member 90. In this manner, the elongate inner member 90acts as a bumper, wherein the distal end abuts the end of the stent 150during stent 150 deployment.

In FIG. 5(b), the stent 150 is loaded on the elongate inner member 90.The stent 150 thus surrounds the elongate inner member 90. Theconfigurations shown in FIGS. 5(a) and 5(b) are within the scope of theinvention.

A description will now be given of the operation of the handle device 2.For ease of description, it is assumed that the stent 150 or otherdevice is loaded and the elongate inner member 90 is within the outertubular member 110 or flexible sheath 114. Initially, the elongate innermember 90 is secured to the body portion of the handle member 4 bypressing the proximal attachment member 96 into the inner member recess20. The elongate inner member 90 is thus fixed (in the axial direction)with respect to the handle device 2. In one aspect of the invention, thecontrol member 30, which is located within the control member guide 16,is then affixed to the outer tubular member 110. If a hemostatic valveassembly 60 is used, the control member 30 is attached to the hemostaticvalve assembly 60. At this point, the control knob 50 is in positionwithin the handle device 2 with the shaft 54 engaging with the needlebearing clutch 130. The teeth 57 of the gear 56 are engaged with thecorresponding teeth 34 of the rail 32. During deployment of the stent150, the outer tubular member 110 is retracted in the proximaldirection, while the elongate inner member 90 remains fixed in the axialdirection. The control knob 50, which is rotatable in only one directiondue to the needle bearing clutch 130, retracts the control member 30within the handle device 2. The outer tubular member 110, which isengaged with the control member 30, is retracted as well. The outertubular member 110 is retracted until the stent 150 or other device isdeployed. Since the shaft 54 of the control knob 50 engages with theneedle bearing clutch 130, the control knob 50 turns in only onedirection to retract the outer tubular member 110 in the proximaldirection. It should be appreciated that the handle device 2 isunidirectional in that the outer tubular member 110 is only moveable inone direction, the proximal direction, relative to the elongate innermember 90.

The unidirectional aspect of the handle device 2 provides severalbenefits. Initially, the handle device 2 prevents a user fromaccidentally moving the outer tubular member 110 in the distaldirection. In this manner, the outer tubular member 110 cannot collideor push a stent 150 that has already deployed. In addition, the outertubular member 110 is in constant tension during retraction when thehandle device 2 is used. This tension-retaining feature is particularlyimportant because the outer tubular member 110, and in particular theflexible sheath 114, have a tendency to stretch to some extent. With thehandle device 2 described herein, when the outer tubular member 110 orflexible sheath 114 is retracted a certain distance by rotation of thecontrol knob 50 and let go, the tension or stretch in the outer tubularmember 110 or flexible sheath 114 remains. It is generally preferable toretain this tension in the outer tubular member 110. Existing devicesmay not have this tension-retaining effect and recoil to a certainextent, once movement of the sheath stops. In prior devices, the sheathhas a tendency to deform or change the shape once retraction hasstopped.

FIG. 6 illustrates another aspect of the invention. In this aspect, theouter tubular member 110 includes at a proximal end thereof, a controlmember 160. The control member 160 of the outer tubular member 110 isformed contiguous with the outer tubular member 110 and is not separatelike control member 30 shown in FIGS. 1 and 2. The control member 160can be considered part of the outer tubular member 110. Preferably, thecontrol member 160 includes a groove 162 along its length. The groove162 engages with one or more guide pins 24 in the handle member 4. Inaddition, the control member 160 preferably includes teeth 164 along aportion of its length. In this embodiment, the control member 160 passesdirectly into the control member guide 16. The teeth 164 of the controlmember 160 engage with teeth 57 of gear 56. In this aspect, the outertubular member 110 directly engages with the gear 56 of the shaft 54.The shaft 54 is in rotational engagement with the outer tubular member110.

It should be understood that various modifications of theabove-described device are intended to fall within the scope of theclaims. For example, it is possible to eliminate the wheel portion 52 ofthe control knob 50 and control rotational motion by direct manipulationof the shaft 54. Also, while a gear and tooth arrangement has generallybeen described as coupling movement of the shaft 54 with the controlmember guides 30, 160, alternative mechanisms can be employed. Forexample, various gear, screw, and even friction-based arrangements maybe employed to translate unidirectional rotational motion of the shaft54 into linear translation of the outer tubular member 110. Whileembodiments of the present invention have been shown and described,various modifications may be made without departing from the scope ofthe present invention. The invention, therefore, should not be limited,except to the following claims, and their equivalents.

1. A handle apparatus for an endoluminal treatment device, comprising: ahandle member; a control member coupled to the handle member; a shaftmounted to the handle member and coupled to the control member by auni-directional mechanism such that rotation of the shaft is limited toonly one direction and rotation of the shaft displaces the controlmember axially with respect to the handle member.
 2. A handle apparatusaccording to claim 1, wherein the control member comprises a pluralityof teeth on a proximal end thereof, and the shaft includes a gear forengaging the plurality of teeth on the control member to couple rotationof the shaft to axial displacement of the control member.
 3. A handleapparatus according to claim 1, wherein the shaft is substantiallyperpendicular to the control member.
 4. A handle apparatus according toclaim 1, wherein the control member includes a groove along a proximalend portion of the control member, and the handle member includes acontrol member guide for slidably receiving the control membertherethrough, the control member guide including at least one guide pintherein for engaging the groove along the proximal end portion of thecontrol member to prevent rotation of the control member.
 5. A handleapparatus according to claim 1, the handle member including an innermember recess, the elongate inner member being detachably mounted withinthe inner member recess.
 6. A handle apparatus according to claim 1,wherein when the shaft is rotated in the single direction and released,there is substantially no backlash of the control member.
 7. A systemfor delivering an endoluminal prosthesis within a body lumen of apatient, comprising: a handle member; a control member slidably coupledto the handle member; an outer tubular member extending distally fromthe control member; an elongate inner member slidably disposed withinthe outer tubular member and axially fixed with respect to the handlemember; a shaft rotatably mounted to the handle member, the shaftincluding a gear coupled to the control member such that rotation of theshaft displaces the outer tubular member axially with respect to theelongate inner member; and a unidirectional mechanism that limitsrotation of the shaft to only one direction, such that when the shaft isrotated in the one direction, the outer tubular member is directed froma distal position to a proximal position.
 8. The system of claim 7,further comprising a prosthesis within the outer tubular memberproximate its distal end.
 9. The system of claim 8, wherein theprosthesis is deployed from the distal end of the outer tubular memberby rotation of the shaft in the one direction.
 10. The system claim 7,wherein the control member further comprises a rail portion for engagingthe gear of the shaft, and an engagement portion at a distal end of therail portion for coupling the outer tubular member to the controlmember.
 11. The system of claim 10, wherein the rail portion includes aplurality of teeth thereon, and the gear includes a plurality of teeththereon for engaging with the teeth of the rail portion.
 12. The systemof claim 7, wherein the shaft is oriented substantially perpendicular tothe control member.
 13. The system of claim 10, wherein the rail portionincludes a groove disposed thereon, and the handle member includes atleast one guide pin therein, the at least one guide pin engaging withthe groove contained in the rail portion.
 14. The system of claim 7,wherein the handle member includes an inner member recess for securingthe elongate inner member to the handle member.